A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures

• ClinicalTrials.gov Identifier: NCT00938431
• Recruitment Status: Completed
• First Posted: July 13, 2009
• Results First Posted: December 15, 2015
• Last Update Posted: March 19, 2019
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Epilepsy
• Intervention: Drug: Lacosamide
• Enrollment: 47

Participant Flow

Recruitment Details	The SP0847 study began recruitment in October 2009. The study ended in July 2014 with 47 subjects enrolled into the study.
Pre-assignment Details

Arm/Group Title	>=1 Month to <4 Years (Safety Set)	>=4 Years to <12 Years (Safety Set)	>=12 Years to <=17 Years (Safety Set)
Arm/Group Description	Subjects were classified as belonging to the age group based on their age at time of enrollment	Subjects were classified as belonging to the age group based on their age at time of enrollment	Subjects were classified as belonging to the age group based on their age at time of enrollment
Period Title: Overall Study
Started	15	23	9
Completed	9	14	1
Not Completed	6	9	8
Reason Not Completed
Adverse Event	5	8	6
Lack of Efficacy	0	1	0
Did not up titrate to 12 mg kg/day	1	0	0
Dosing compliance issue	0	0	1
Reached maximum dose early	0	0	1

Baseline Characteristics

Arm/Group Title		>=1 Month to <4 Years (Safety Set)	>=4 Years to <12 Years (Safety Set)	>=12 Years to <=17 Years (Safety Set)	Total Title
Arm/Group Description		Subjects were classified as belonging to the age group based on their age at time of enrollment	Subjects were classified as belonging to the age group based on their age at time of enrollment	Subjects were classified as belonging to the age group based on their age at time of enrollment	[Not Specified]
Overall Number of Baseline Participants		15	23	9	47
Baseline Analysis Population Description		The analysis group for Baseline Characteristics is the Safety Set (SS). The SS is all subjects who signed the informed consent form and took at least 1 dose of Lacosamide (LCM) in SP0847.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
Age (years)	Number Analyzed	15 participants	23 participants	9 participants	47 participants
		1.58 (1.02)	7.41 (2.44)	15.15 (1.50)	7.03 (5.12)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	23 participants	9 participants	47 participants
	Female	10 66.7%	9 39.1%	5 55.6%	24 51.1%
	Male	5 33.3%	14 60.9%	4 44.4%	23 48.9%
Weight; Mean (Standard Deviation); Unit of measure: Kilograms
	Number Analyzed	15 participants	23 participants	9 participants	47 participants
		9.90 (3.31)	26.73 (10.20)	54.10 (10.49)	26.60 (17.64)
Height; Mean (Standard Deviation); Unit of measure: Centimeters
	Number Analyzed	15 participants	23 participants	9 participants	47 participants
		79.64 (11.22)	121.81 (14.86)	158.93 (11.43)	115.46 (31.23)
BMI; Mean (Standard Deviation); Unit of measure: Kg/m^2
	Number Analyzed	15 participants	23 participants	9 participants	47 participants
		15.27 (2.33)	17.39 (2.68)	21.38 (3.12)	17.48 (3.37)
Racial Group; Measure Type: Number; Unit of measure: Participants	Number Analyzed	15 participants	23 participants	9 participants	47 participants
Asian		1	1	0	2
Black		0	4	3	7
White		7	18	5	30
Other/ Mixed		7	0	1	8
Ethnicity; Measure Type: Number; Unit of measure: Participants	Number Analyzed	15 participants	23 participants	9 participants	47 participants
Hispanic or Latino		11	7	3	21
Not Hispanic or Latino		4	16	6	26

Outcome Measures

1. Primary Outcome

Title	Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks)
Description	[Not Specified]
Time Frame	13 weeks

Outcome Measure Data

Analysis Population Description

The analysis consists of the Safety Set (SS), which is all subjects who signed the informed consent form and took at least 1 dose of Lacosamide (LCM) in SP0847.

Arm/Group Title	>=1 Month to <4 Years (Safety Set)	>=4 Years to <12 Years (Safety Set)	>=12 Years to <=17 Years (Safety Set)
Arm/Group Description:	Subjects were classified as belonging to the age group based on their age at time of enrollment	Subjects were classified as belonging to the age group based on their age at time of enrollment	Subjects were classified as belonging to the age group based on their age at time of enrollment
Overall Number of Participants Analyzed	15	23	9
Measure Type: Number; Unit of Measure: participants
	14	19	9

2. Secondary Outcome

Title	Change in Seizure Frequency From Baseline to End of Treatment
Description	[Not Specified]
Time Frame	From Baseline to End of Treatment (approximately 13 weeks)

Outcome Measure Data

Analysis Population Description

This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.

Arm/Group Title	>=1 Month to <4 Years (Full Analysis Set)	>=4 Years to <12 Years (Full Analysis Set)	>=12 Years to <=17 Years (Full Analysis Set)
Arm/Group Description:	Subjects were classified as belonging to the age group based on their age at time of enrollment	Subjects were classified as belonging to the age group based on their age at time of enrollment	Subjects were classified as belonging to the age group based on their age at time of enrollment
Overall Number of Participants Analyzed	14	23	9
Mean (Standard Deviation); Unit of Measure: percentage change
	18.94 (111.44)	18.38 (88.16)	34.59 (92.45)

3. Secondary Outcome

Title	Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination
Description	For the assessment of the Caregiver Global Impression of Change, the caregiver (including parent/legal guardian) provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of Adverse Events (AEs), and subject's functional status. The caregiver will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline: Very much improved; Much improved; Minimally improved; No change; Minimally worse; Much worse; Very much worse
Time Frame	Visit 5 (Day 27/28) or Early Termination

Outcome Measure Data

Analysis Population Description

This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.

Arm/Group Title	>=1 Month to <4 Years (Full Analysis Set)	>=4 Years to <12 Years (Full Analysis Set)	>=12 Years to <=17 Years (Full Analysis Set)
Arm/Group Description:	Subjects were classified as belonging to the age group based on their age at time of enrollment	Subjects were classified as belonging to the age group based on their age at time of enrollment	Subjects were classified as belonging to the age group based on their age at time of enrollment
Overall Number of Participants Analyzed	14	23	9
Measure Type: Number; Unit of Measure: Participants
Very Much Improved	3	2	0
Much Improved	7	8	4
Minimally Improved	3	8	3
No Change	0	2	1
Miniamally Worse	0	1	0
Much Worse	0	2	0
No data available	1	0	1

4. Secondary Outcome

Title	Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination
Description	For assessment of the Clinical Global Impression of Change, the investigator provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status. The investigator will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline: Very much improved; Much improved; Minimally improved; No Change; Minimally worse; Much worse; Very much worse
Time Frame	Visit 5 (Day 27/28) or Early Termination

Outcome Measure Data

Analysis Population Description

This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.

For one subject in the age group >=12 years to <=17 years no data is available.

Arm/Group Title	>=1 Month to <4 Years (Full Analysis Set)	>=4 Years to <12 Years (Full Analysis Set)	>=12 Years to <=17 Years (Full Analysis Set)
Arm/Group Description:	Subjects were classified as belonging to the age group based on their age at time of enrollment	Subjects were classified as belonging to the age group based on their age at time of enrollment	Subjects were classified as belonging to the age group based on their age at time of enrollment
Overall Number of Participants Analyzed	14	23	9
Measure Type: Number; Unit of Measure: Participants
Very Much Improved	2	2	0
Much Improved	6	7	7
Minimally Improved	4	9	1
No Change	1	2	0
Minimally Worse	0	3	0
Much Worse	1	0	0
No data available	0	0	1

5. Secondary Outcome

Title	Plasma Ctrough Values for Lacosamide at Day 7
Description	During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.

The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Arm/Group Title	All Subjects (Safety Set)
Arm/Group Description:	All subjects from >=1 month to <=17 years
Overall Number of Participants Analyzed	45
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: μg/mL
	839.9; (64.1%)

6. Secondary Outcome

Title	Plasma Ctrough Values for Lacosamide at Day 28
Description	During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.
Time Frame	Day 28

Outcome Measure Data

Analysis Population Description

The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.

The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Arm/Group Title	All Subjects (Safety Set)
Arm/Group Description:	All subjects from >=1 month to <=17 years
Overall Number of Participants Analyzed	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: μg/mL
	3886.0; (70.2%)

7. Secondary Outcome

Title	Plasma Ctrough Values for Lacosamide at Day 35
Description	During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.
Time Frame	Day 35

Outcome Measure Data

Analysis Population Description

The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.

The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Arm/Group Title	All Subjects (Safety Set)
Arm/Group Description:	All subjects from >=1 month to <=17 years
Overall Number of Participants Analyzed	5
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: μg/mL
	4033.8; (52.5%)

8. Secondary Outcome

Title	Plasma Ctrough Values for Lacosamide at Day 42
Description	During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.
Time Frame	Day 42

Outcome Measure Data

Analysis Population Description

The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.

The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Arm/Group Title	All Subjects (Safety Set)
Arm/Group Description:	All subjects from >=1 month to <=17 years
Overall Number of Participants Analyzed	14
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: μg/mL
	4169.5; (73.3%)

9. Secondary Outcome

Title	Plasma Ctrough Values for SPM 12809 at Day 7
Description	SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.

The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Arm/Group Title	All Subjects (Safety Set)
Arm/Group Description:	All subjects from >=1 month to <=17 years
Overall Number of Participants Analyzed	45
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: μg/mL
	258.4; (44.6%)

10. Secondary Outcome

Title	Plasma Ctrough Values for SPM 12809 at Day 28
Description	SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.
Time Frame	Day 28

Outcome Measure Data

Analysis Population Description

The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.

The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Arm/Group Title	All Subjects (Safety Set)
Arm/Group Description:	All subjects from >=1 month to <=17 years
Overall Number of Participants Analyzed	6
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: μg/mL
	754.9; (21.1%)

11. Secondary Outcome

Title	Plasma Ctrough Values for SPM 12809 at Day 35
Description	SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.
Time Frame	Day 35

Outcome Measure Data

Analysis Population Description

The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.

The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Arm/Group Title	All Subjects (Safety Set)
Arm/Group Description:	All subjects from >=1 month to <=17 years
Overall Number of Participants Analyzed	5
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: μg/mL
	955.1; (24.7%)

12. Secondary Outcome

Title	Plasma Ctrough Values for SPM 12809 at Day 42
Description	SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM. The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.
Time Frame	Day 42

Outcome Measure Data

Analysis Population Description

The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.

The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Arm/Group Title	All Subjects (Safety Set)
Arm/Group Description:	All subjects from >=1 month to <=17 years
Overall Number of Participants Analyzed	14
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: μg/mL
	1725.8; (39.4%)

Adverse Events

Time Frame	Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set.
Adverse Event Reporting Description	The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.
Arm/Group Title	>=1 Month to <4 Years (Safety Set)		>=4 Years to <12 Years (Safety Set)		>=12 Years to <=17 Years (Safety Set)
Arm/Group Description	Subjects were classified as belonging to the age group based on their age at time of enrollment		Subjects were classified as belonging to the age group based on their age at time of enrollment		Subjects were classified as belonging to the age group based on their age at time of enrollment
All-Cause Mortality
	>=1 Month to <4 Years (Safety Set)		>=4 Years to <12 Years (Safety Set)		>=12 Years to <=17 Years (Safety Set)
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--
Serious Adverse Events
	>=1 Month to <4 Years (Safety Set)		>=4 Years to <12 Years (Safety Set)		>=12 Years to <=17 Years (Safety Set)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/15 (20.00%)		3/23 (13.04%)		0/9 (0.00%)
Gastrointestinal disorders
Gastrointestinal inflammation * 1	0/15 (0.00%)	0	1/23 (4.35%)	1	0/9 (0.00%)	0
Infections and infestations
Pneumonia viral * 1	1/15 (6.67%)	1	0/23 (0.00%)	0	0/9 (0.00%)	0
Viral upper respiratory tract infection * 1	0/15 (0.00%)	0	1/23 (4.35%)	1	0/9 (0.00%)	0
Metabolism and nutrition disorders
Dehydration * 1	1/15 (6.67%)	1	0/23 (0.00%)	0	0/9 (0.00%)	0
Nervous system disorders
Status epilepticus * 1	2/15 (13.33%)	2	1/23 (4.35%)	1	0/9 (0.00%)	0
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA16.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	>=1 Month to <4 Years (Safety Set)		>=4 Years to <12 Years (Safety Set)		>=12 Years to <=17 Years (Safety Set)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/15 (73.33%)		16/23 (69.57%)		7/9 (77.78%)
Gastrointestinal disorders
Vomiting * 1	1/15 (6.67%)	3	7/23 (30.43%)	7	2/9 (22.22%)	2
Diarrhoea * 1	2/15 (13.33%)	2	4/23 (17.39%)	7	1/9 (11.11%)	1
Constipation * 1	1/15 (6.67%)	1	1/23 (4.35%)	1	1/9 (11.11%)	1
General disorders
Irritability * 1	3/15 (20.00%)	3	1/23 (4.35%)	1	1/9 (11.11%)	1
Pyrexia * 1	2/15 (13.33%)	2	3/23 (13.04%)	4	0/9 (0.00%)	0
Gait disturbance * 1	0/15 (0.00%)	0	2/23 (8.70%)	2	1/9 (11.11%)	1
Infections and infestations
Otitis media * 1	0/15 (0.00%)	0	3/23 (13.04%)	3	0/9 (0.00%)	0
Pharyngotonsillitis * 1	3/15 (20.00%)	3	0/23 (0.00%)	0	0/9 (0.00%)	0
Nervous system disorders
Somnolence * 1	2/15 (13.33%)	2	3/23 (13.04%)	3	1/9 (11.11%)	1
Dizziness * 1	0/15 (0.00%)	0	3/23 (13.04%)	4	2/9 (22.22%)	2
Balance disorder * 1	0/15 (0.00%)	0	1/23 (4.35%)	2	2/9 (22.22%)	2
Skin and subcutaneous tissue disorders
Rash * 1	1/15 (6.67%)	1	1/23 (4.35%)	1	2/9 (22.22%)	2
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA16.1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.

Results Point of Contact

• Name/Title: Study Director
• Organization: UCB
• Phone: +1877 822 9493

Publications of Results:

Winkler J, Schoemaker R, Stockis A. Population Pharmacokinetics of Adjunctive Lacosamide in Pediatric Patients With Epilepsy. J Clin Pharmacol. 2019 Apr;59(4):541-547. doi: 10.1002/jcph.1340. Epub 2018 Nov 14.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00938431
• Other Study ID Numbers: SP0847; 2011-001558-27 ( EudraCT Number )
• First Submitted: July 2, 2009
• First Posted: July 13, 2009
• Results First Submitted: June 29, 2015
• Results First Posted: December 15, 2015
• Last Update Posted: March 19, 2019